BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR

    MDR report key: 15048356 · Received July 18, 2022

    Report

    Report Number
    3003916417-2022-00113
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Date of Event
    June 21, 2022
    Report Date
    September 6, 2022
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2062402, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2022-04-01. MEDICAL DEVICE LOT #: 1357749, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2022-01-18. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO FIBRIN WERE OBSERVED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, FIBRIN STRAND(S), BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. ALL TUBES PERFORMED AS EXPECTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE FIBRIN. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO FIBRIN WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR WAS MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER CENTRIFUGING THE SAMPLES, THE MATERIAL IS PRESENTING FIBRIN, SO CUSTOMER NEEDS TO WAIT LONGER TO CENTRIFUGE, UNDERGOING THE RISK OF LOOSING SAMPLE QUALITY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR WAS MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER CENTRIFUGING THE SAMPLES, THE MATERIAL IS PRESENTING FIBRIN, SO CUSTOMER NEEDS TO WAIT LONGER TO CENTRIFUGE, UNDERGOING THE RISK OF LOOSING SAMPLE QUALITY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719201 BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown